Trial Outcomes & Findings for Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder (NCT NCT01766401)
NCT ID: NCT01766401
Last Updated: 2019-12-18
Results Overview
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
402 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2019-12-18
Participant Flow
Participant milestones
| Measure |
Placebo
Dose-matched placebo tablets, oral administration, once per day
|
Vilazadone
Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
200
|
|
Overall Study
COMPLETED
|
161
|
144
|
|
Overall Study
NOT COMPLETED
|
37
|
56
|
Reasons for withdrawal
| Measure |
Placebo
Dose-matched placebo tablets, oral administration, once per day
|
Vilazadone
Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
22
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Protocol Violation
|
3
|
8
|
|
Overall Study
Withdrawal by Subject
|
15
|
12
|
|
Overall Study
Lost to Follow-up
|
10
|
11
|
|
Overall Study
Pregnancy
|
1
|
1
|
Baseline Characteristics
Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=198 Participants
Dose-matched placebo tablets, oral administration, once per day
|
Vilazadone
n=200 Participants
Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
|
Total
n=398 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.1 Years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
40.5 Years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
40.3 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Age, Customized
< 20
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Customized
20-29
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Age, Customized
30-39
|
51 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Customized
40-49
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Customized
50-59
|
37 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Age, Customized
≥ 60
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
67 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
131 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
161 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
160 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
32 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of the HAM-A.
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Outcome measures
| Measure |
Placebo
n=197 Participants
Dose-matched placebo tablets, oral administration, once per day
|
Vilazadone
n=198 Participants
Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
|
|---|---|---|
|
Change in Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
|
14.9 Score on Scale
Standard Deviation 7.37
|
13.5 Score on Scale
Standard Deviation 7.41
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of the HAM-A.
The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe).
Outcome measures
| Measure |
Placebo
n=197 Participants
Dose-matched placebo tablets, oral administration, once per day
|
Vilazadone
n=198 Participants
Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
|
|---|---|---|
|
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
|
10.1 Score on Scale
Standard Deviation 6.58
|
7.8 Score on Scale
Standard Deviation 6.91
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 75 other events
Deaths: 0 deaths
Vilazadone
Serious events: 0 serious events
Other events: 130 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=198 participants at risk
Dose-matched placebo tablets, oral administration, once per day
|
Vilazadone
n=200 participants at risk
Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.6%
19/198 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
31.5%
63/200 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.1%
24/198 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
31.0%
62/200 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
2/198 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
6.6%
13/198 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Gastrointestinal disorders
Dry mouth
|
5.1%
10/198 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
5.5%
11/200 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
10/198 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
4.5%
9/200 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Dizziness
|
7.1%
14/198 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
7.5%
15/200 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Headache
|
10.6%
21/198 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
7.5%
15/200 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Somnolence
|
3.0%
6/198 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
6.0%
12/200 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Psychiatric disorders
Abnormal dreams
|
1.5%
3/198 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
5.0%
10/200 • Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the PI will be subject to mutual agreement between the PI and Forest Research Institute, Inc.
- Publication restrictions are in place
Restriction type: OTHER